Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment

Prior treatment

• Prior treatment with taxane as first line treatment;
• Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway)
• MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (\>10 mg/d prednisone or equivalent) \> 4 weeks before randomization can participate in the study;

Other illness

• Active hepatitis B or hepatitis C.

Other

• Meningeal carcinomatosis;
• Pregnancy or lactation;

• Metastatic or recurrent triple negative breast cancer (TNBC);
• Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
• Eligible for taxane monotherapy;
• No more than one line of chemotherapy in metastatic setting;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy of 12 weeks or more;
• At least one measurable lesion per RECIST v1.1;
• Demonstrate adequate hematologic and organ functions as defined in the protocol